Device class
Class II
Regulation 888.3535
Total clearances
3
2022-10-28 → 2025-09-02
Definition
What is Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.
Classification details
Medical specialty
Orthopedic
Regulation number
888.3535
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Ignite Orthomotion |
2 |
1 |
2025-09-02 |
|
Smith+Nephew, Inc. |
1 |
0 |
2022-10-28 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 27446 |
CPT
|
— |
High
|
Arthroplasty, knee, unicompartmental; uncemented or bone surface, porous-coated |
| C1719 |
HCPCS
|
Brachytherapy source, non-stranded, non-high dose rate iridium-192, per source ✓ CMS-verified description |
High
|
Knee prosthesis, unicompartmental, metal/polymer |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-09-02 |
K251975 |
Ignite Orthomotion
|
Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component |
| 2024-12-16 |
K242307 |
Ignite Orthomotion
|
ACHIEVE Partial Knee System |
| 2022-10-28 |
K222653 |
Smith+Nephew, Inc.
|
JOURNEY II UK and ENGAGE Cementless Partial Knee System |